The Nalu Team - Nalu Medical
Nalu Announces Publication of Results from COMFORT Randomized Controlled Trial (RCT) Demonstrating Sustained Pain Relief and Functional Improvements Over 24 Months
The 24-month results of the COMFORT Peripheral Nerve Stimulation (PNS) RCT were published on January 23, 2026 in the peer-reviewed journal Chronic Pain & Management. These results demonstrate that treatment with the Nalu Neurostimulation System resulted in durable, consistent and statistically significant improvements for chronic intractable pain, regardless of the area of the body treated and efficacy metric used.
At 24 months,
- 85% of the Active Arm and Crossover Arm were classified as responders (≥50% pain reduction) with an average pain reduction of 67%, consistent with previously published data.
- 28% were high responders (≥80% pain reduction).
- 74% of subjects experienced clinically significant improvement in functionality (p<0.001) as reported by the ODI.
- 72% of subjects reported a clinically meaningful improvement in quality of life (p<0.001).
- 96% of subjects were satisfied with the therapy.
“The 24-month outcomes of the COMFORT RCT confirm what we have seen clinically — that peripheral nerve stimulation therapy with the Nalu Neurostimulation System results in clinically significant improvement in patient symptoms, quality of life, and general well-being,” said Mitch Engle, MD, PhD, lead author of the paper. “These robust results reinforce the efficacy and safety of the Nalu Neurostimulation System with consistent pain relief across multiple anatomical targets at all time points, from 3 to 24 months.”
Tom West, Nalu CEO and President stated, “The 24-month outcomes provide further proof that the Nalu Neurostimulation System delivers clinically meaningful and sustained relief in patients with chronic intractable neuropathic pain. The consistency of results over the last 24 months, and the reproducible outcomes across a range of nerve targets give confidence that the Nalu Neurostimulation System is an effective PNS solution for localized pain.”
Consensus Guidelines for the Use of Peripheral Nerve Stimulation in the Treatment of Chronic Pain and Neurological Diseases: A Neuron Project from the American Society of Pain and Neuroscience
Peripheral nerve stimulation (PNS) has evolved substantially over recent decades in terms of hardware and evidence supporting efficacy. Treatment targets continue to expand and address both pain and functional applications. The American Society of Pain and Neuroscience (ASPN) seeks to substantially update and expand upon a review of the evidence supporting PNS as well as provide guidelines for clinical practice. A diverse multidisciplinary panel of experts was selected to provide opinions and guidance based on evidence-graded assessment and clinical knowledge. This document aims to serve as a resource for clinicians and payors in the interest of expanding awareness of the breadth of research in the field of PNS and expanding access to therapy.